8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

October 22, 2025

Date of Report (Date of the earliest event reported)

Simulations Plus, Inc.

(Exact name of registrant as specified in its charter)

California	001-32046	95-4595609
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

800 Park Offices Drive, Suite 401, Research Triangle Park, NC 27709

(Address of principal executive offices) (Zip Code)

661-723-7723

Registrant's telephone number, including area code

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14z-12 under Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	SLP	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging Growth Company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 2.02    Results of Operations and Financial Condition

On October 22, 2025, Simulations Plus, Inc. (the “Company”) issued a press release (the “Press Release”) announcing certain preliminary operational results for its fourth fiscal quarter ended August 31, 2025, and providing its guidance and estimates for the fiscal year ending August 31, 2026. A copy of such Press Release is attached as Exhibit 99.1 to this Current Report on Form 8-K (the “Report”)

Item 7.01    Regulation FD Disclosure

As described above in “Item 2.02 Results of Operations and Financial Condition,” on October 22, 2025, the Company issued the Press Release announcing certain preliminary operational results for its fourth fiscal quarter ended August 31, 2025 and providing its guidance and estimates for the fiscal year ending August 31, 2026. A copy of such Press Release is attached to this Report as Exhibit 99.1.

In accordance with General Instructions B.2 of Form 8-K, the information in Items 2.02 and 7.01 of this Report and the Exhibit 99.1 attached, is intended to be “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Except as shall be expressly set forth by specific reference in such filing, the information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This Report, including the disclosures set forth herein and, in the Exhibit, attached hereto, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,” “estimates,” “believes” and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements.

Forward-looking statements in this Report or reports hereafter furnished, including in other publicly available documents filed with the Securities and Exchange Commission (the “Commission”), to the Company’s stockholders and other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from those expressed or implied by such forward-looking statements.

Item 9.01    Financial Statements and Exhibits

(d)    Exhibits

Exhibit Number	Description
99.1	Press Release - October 22, 2025
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	SIMULATIONS PLUS, INC.
Dated: October 22, 2025	By: /s/ Will Frederick
	Will Frederick
	Executive Vice President and Chief Financial Officer

3

Document

For Immediate Release:

October 22, 2025

Simulations Plus Announces Preliminary Fiscal Year 2025 Results and Fiscal Year 2026 Guidance

Provides preliminary fiscal 2026 revenue guidance of $79 to $82 million and adjusted diluted EPS guidance of $1.03 to $1.10

Fourth quarter and fiscal year 2025 results to be reported December 1, 2025

RESEARCH TRIANGLE PARK, NC, October 22, 2025– Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a leading provider of cheminformatics, biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today announced preliminary results for its fiscal year 2025 and issued preliminary guidance and management outlook for fiscal year 2026 as follows:

	Fiscal 2025 Preliminary	Fiscal 2026 Guidance
Revenue	$79.1M	$79M – $82M
Revenue growth	13%	0 – 4%
Software mix	58%	57 – 62%
Adjusted EBITDA margin	28%	26 – 30%
Adjusted diluted EPS	$1.03	$1.03 - $1.10

The fiscal 2025 preliminary results and fiscal 2026 guidance set forth above are preliminary and unaudited based on currently available information and management estimates and are subject to adjustment in the final audited financial statements to be filed with the Company’s Annual Report on Form 10-K for the full fiscal year 2025, expected to be filed on December 1, 2025.

“We expect to successfully meet our revised fiscal 2025 guidance despite operating in a challenging market environment shaped by ongoing uncertainty around funding, drug pricing, and tariffs affecting both our pharmaceutical and biotech clients,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “Looking ahead, we are issuing preliminary guidance for fiscal 2026 based on the assumption that current market conditions remain stable.

“As part of our ongoing commitment to innovation, we are excited to unveil our new product vision, which is designed to accelerate delivery of software enhancements, deepen platform integration, and advance our AI capabilities. The recent launch of GastroPlus® X.2 (GPX.2) marks the debut of our AI-powered tools on the S+ Cloud—an important first step in our broader, integrated Cloud and AI strategy. Over the next year, we plan to expand these capabilities across our other flagship platforms, delivering greater value to our clients through enhanced productivity, richer data insights, and streamlined decision support. We look forward to sharing additional details when we report our fiscal 2025 results in December.”

Upcoming Investor Events

Shawn O’Connor will be participating in the following investor events:

KeyBanc Non-Deal Roadshow

Format: One-on-one meetings

When: Tuesday, October 28, 2025

Location: Virtual

Stephens Annual Investment Conference 2025

Format: Fireside chat and one-on-one meetings

When: Wednesday, November 19, 2025, at 2:00 PM ET

Location: Nashville, Tennessee

BTIG Digital Health Forum

Format: Fireside chat, thematic panel, and one-on-one meetings

When: Monday, November 24, 2025, at 2:00 PM ET

Location: Virtual

TD Cowen 3rd Annual Diagnosing Tomorrow Conference: Tools & Technologies for the Next Decade

Format: Fireside chat and one-on-one meetings

When: Thursday, December 11, 2025, more details to follow

Location: New York City

For more information about the events or questions about registration, interested parties should visit the investor relations page of the Simulations Plus website or reach out to their contacts at the sponsoring firms.

Fourth Quarter and Fiscal 2025 Press Release, Webcast, and Conference Call Details

The Company will report fourth quarter and fiscal 2025 financial results after the market close on Monday, December 1, 2025.

Shawn O’Connor, Chief Executive Officer, and Will Frederick, Executive Vice President and Chief Financial Officer, will host a conference call and webcast on the same day at 5:00 p.m. Eastern Time to discuss the results and certain forward-looking information. The call may be accessed by registering here or by calling 1-877-451-6152 (domestic) or 1-201-389-0879 (international). The webcast can be accessed on the investor relations page of the Simulations Plus website https://www.simulations-plus.com/investorscorporate-profile/corporate-profile/ where it will also be available for replay approximately one hour following the call.

About Simulations Plus, Inc.

With more than 25 years of experience serving clients globally, Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | X | YouTube.

Environmental, Social, and Governance (ESG)

We focus our Environmental, Social, and Governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, please visit our website to read our 2024 ESG update.

Preliminary Financial Results and Financial Guidance

The preliminary financial results set forth above for the fourth quarter and fiscal 2025 reflect preliminary, unaudited estimates with respect to such results based solely on currently available information, which is subject to change. Such preliminary results are subject to the finalization of quarter-end financial and accounting procedures. While carrying out such procedures, Simulations Plus may identify items that would require it to make adjustments to the preliminary estimates of financial results set forth herein. As a result, our actual financial results could differ than the information set forth herein and such differences could be material. Preliminary results should not be viewed as a substitute for our full quarterly financial statements for the three months ended August 31, 2025, which are being prepared in accordance with U.S. GAAP

In addition, full year fiscal 2026 revenue guidance and management estimates should not be viewed as a substitute for full audited financial statements prepared in accordance with GAAP. Such guidance is based on current assumptions subject to change, are estimates that have not been reviewed by the Company’s auditors, and the Company undertakes no obligation to update these statements except as required by law.

Forward-Looking Statements

Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “will”, “can”, “believe”, “expect,” “anticipate” and similar expressions (or the negative of such terms, as well as other words or expressions referencing future events, conditions or circumstances) mean that these are our best estimates as of this writing, but there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results may differ materially from those statements. Forward looking statements contained in this press release include, but are not limited to, the quotation of our Chief Executive Officer relating to our future performance and growth, statements relating to full fiscal year 2026 revenue guidance and other statements about future events. Factors that could cause or contribute to such differences include, but are not limited to: effectiveness of our new operational structure our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly, annual and current reports and filed with the U.S. Securities and Exchange Commission. The statements are based on current assumptions and are subject to change. The Company undertakes no obligation to update these statements except as required by law.

CONTACT:

Financial Profiles

Lisa Fortuna

310-622-8251

slp@finprofiles.com